MX2011002774A

MX2011002774A - Packing for inserter.

Info

Publication number: MX2011002774A
Application number: MX2011002774A
Authority: MX
Inventors: Richard Morgan Hickmott; Henrik Jeppesen
Original assignee: Unomedical As
Priority date: 2008-09-29
Filing date: 2009-09-28
Publication date: 2011-04-26
Also published as: IL211622A0; JP2012504000A; EP2349056A1; BRPI0919548A2; US20110226652A1; RU2011117291A; AU2009295847A1; CA2736320A1; CN102164560A; WO2010034830A1; KR20110095239A

Abstract

The invention concerns a kit comprising a medical device having an insertion needle and a packing providing a sterile protection for the medical device, such a medical device can be used for an infusion device providing continued medication with e.g. insulin to a patient. More precisely the invention relates to an assembly comprising a medical device comprising a mounting pad having an adhesive surface and an inserter which inserter comprises an insertion needle and a packing providing a sterile protection for the medical device which packing partly comprises a rigid material (1, 2, 7, 8, 5) and partly a soft material (10), wherein the rigid material is constructed of two angularly positioned and rigidly joined surfaces, a first and a second surface (1, 2), which surfaces (1, 2) cover two sides of the medical device (3, 4) which sides face two different directions and the non-adhesive surface of the mounting pad is not covered by a rigid surface.

Description

INSERT PACKAGING DESCRIPTION OF THE INVENTION The invention relates to a kit comprising a medical device having an insertion needle and a package that provides sterile protection for the medical device.

Single-use packages for medical devices that have an insertion needle are well known. Preferred single-use packages must be economical to manufacture and must be capable of providing a sterile environment for the medical device until the device is unpacked by the user and the insertion needle without additional sterilization of the medical device can penetrate in a manner Secure the patient's skin.

WO 2007/122207 shows a package for a skin-friendly device comprising a coated sealing member. The assembly comprises a device (10) that can be placed on the skin with an adhesive mounting surface (31), the device is arranged in a package (20) comprising an opening with a surrounding portion and which is closed with a member (40) sealingly connected to the surrounding portion (22). So it provides a closed space for the device. The sealing member has an inner surface I releasably connected to the adhesive, the sealing member can be penetrated by a sterilizing gas, wherein the inner surface partially coated with a material (42, 44) allows the sealing member detaches from the adhesive, even allows the sterilization gas to penetrate the sealing member. In this way, a sealing member is provided which to a high degree has two desirable properties: it is gas that can penetrate and even allow the sealing member to detach from the adhesive surface.

The present invention provides an assembly comprising a medical device comprising a mounting pad having an adhesive surface and an inserter whose inserter comprises an insertion needle and - a package that provides a sterile protection for the medical device whose packaging partially comprises a rigid material and partially a soft material. The rigid material is constructed of two rigidly attached and angled surfaces, first and second surfaces whose surfaces cover two sides of the medical device whose sides face two different directions and the non-adhesive surface of the mounting pad is not covered. by a rigid surface. That the surfaces are "rigidly joined" means that they join together like a joint, that is, displacement of one surface with the influence on the other surface but the flexibility between the two surfaces can be regulated by the choice of material and thickness of material. The adhesive surface and the non-adhesive surface of the mounting pad are placed opposite each other, this means that when the non-adhesive surface of the mounting pad does not cover the rigid surface, the non-adhesive surface confronts a potential opening through the which medical device can be removed from the package.

According to one embodiment, the second surface provides a contact surface for the adhesive surface of the '. mounting pad. That the rigid material provides a contact surface means that the rigid material touches the adhesive surface by directly providing a protective surface that must be removed before use or that the rigid material supports a protective layer whose protective layer is in direct contact with the surface. adhesive surface. The rigid material normally covers the entire area of the adhesive surface of the mounting pad but can only be in actual contact with the adhesive surface or its protective layer in some areas or designed points.

According to one embodiment, the package is provided with lateral portions formed of rigid material whose side parts connect the two rigidly joined surfaces so that they form a non-flexible structure. This modality makes it easier for the individual package to support external forces that impact the package. Also, it is simpler to replace a soft material that provides sterile conditions within the package.

According to one embodiment, the package is internally provided with a distance piece inserted between the medical device and the first surface or a lateral part of the package. The distance piece makes it possible to hold the medical device when the medical device is placed in the package before use.

According to one embodiment, the edge of the rigid material has a flat circumferential portion (5) surrounding an opening defined by the edge of the rigid material to which the circumferential portion (5) of a protective seal of soft material (10) can be connected. releasably. The medical device can be removed from the package and replaced in the package through the opening formed by the edge of the rigid material.

According to one embodiment, the rigid material is molded in one piece.

According to one embodiment, the package comprises means for resealing. The package does not necessarily have to be closed completely, but it must be closed to a degree where the medical device is secured in the package after use. According to this embodiment, the means for resealing may comprise an adhesive and / or mechanical means.

If the means for resealing is adhesive, it can be provided by an adhesive or sticky material placed between the soft material and the circumferential portion. The sticky material can be placed all along the circumferential portion 5 or on the soft material during manufacture or it can be placed in portions. The sticky material can be, for example, PA (polyamide).

If the means for resealing is mechanical, it can be provided by one or more openings in the soft material whose openings correspond to the projected portions of the rigid material.

According to one embodiment, the inserter of the medical device is releasably connected to a base part whose base part will be placed on the skin of the patient. The base part is of such size that a part of the supply comprising a reservoir can be connected directly to the base part. A deposit usually contains 1-10 mi.

According to another aspect of the invention, the invention comprises a package that provides a sterile protection for a medical device stored in the package whose packaging partially comprises a rigid material and partially a soft material. The rigid material is constructed of two angularly placed and rigidly joined surfaces, first and second surfaces whose surfaces cover two sides of the medical device whose sides face two different directions and the non-adhesive surface of the mounting pad is not covered. by a rigid surface.

Definitions When relative terms such as "superior", "inferior", "right", "left", "horizontal", "vertical" or similar terms are used, the terms refer to the appended figures and not necessarily to a situation of use real .

Rigid material - can not be penetrated by an insertion needle and is capable of holding a certain space.

Soft material - can be penetrated by an insertion needle, for example, can be penetrated by sterilization gas, can be bent or folded by the user, that is, the material does not necessarily hold a certain shape during use.

BRIEF DESCRIPTION OF THE DRAWINGS A detailed description of the embodiments of the present invention will be made with reference to the appended figures, in which like numbers designate corresponding parts in different figures.

Figure 1 shows a first embodiment of the rigid part of a package in which a medical device is placed comprising an inserter combined with a part of the assembly.

Figure 2 shows a second embodiment of the rigid part of a package in which a medical device is placed comprising an inserter combined with a part of the assembly.

Figure 3 shows the first embodiment of the rigid part of a package without the medical device.

Figure 4 shows the second embodiment of the rigid part of a package without the medical device.

Figure 5 shows how the first and second packing modes can be nested if ten units are packed together.

Figures 6A and 6B show the first embodiment of the package seen from above from above and provided with a soft protective layer.

Figures 7A and 7B show the second embodiment of the package viewed in a respective manner from below and provided with a soft protective layer.

Figures 8A and 8B show how the soft and rigid materials can be combined and a modality of mechanical resealing of a lid in the package.

Figures 9A and 9B illustrate a medical device in the form of an inserter connected to a base plate through which a cannula part can be inserted.

Figure 1 shows a first embodiment of an assembly according to the invention, the assembly of which comprises an inserter 3 combined with a base part 4 provided with a mounting pad and a packing. The inserter comprising an insertion needle and combined with a base part, which will be connected to a patient, is illustrated in greater detail in Figures 9A and 9B. Only the rigid material of the package is shown in Figure 1 as a cover of soft material that has been remitted to be able to see the inserter inside the package.

The rigid material is constructed of two surfaces arranged in an angular manner and rigidly joined together, a first and a second surface 1, 2. The packing is further provided with the two connecting side parts 7, 8 and the edge of the four sides of the rigid material has a flat circumferential portion 5 surrounding an opening defined by the edge of the rigid material. A protective seal 10 of soft material can be releasably connected to the circumferential portion 5. A part 6 of the circumferential portion 5 can be separated from the rigid material and then operate as a handle whose handle can be non-releasably connected to the protective seal of the soft material. In Figure 1, the handle 6 is still in the position that holds it before use while the protective seal of soft material has been removed, this is not a situation that would normally occur during use, but the packaging is shown without the protective seal to illustrate the inside of the package. The package is provided internally with a distance piece 9 inserted between the inserter 3 and the first surface of the package. The distance piece 9 makes it possible for the user to hold the inserter 3 with a clamp-type clamp of, for example, the index finger and the thumb. As an alternative to a distance piece 9, the rigid material of the package could be provided with a finger grip space, i.e., a local extension of the cross section of the package along the first surfaces, which provides sufficient space for make it possible for the user to put one or two fingers behind the medical device.

In Figure 1, the second surface 2 functions as a support on whose support the inserter including the base part can be left while the user has, for example, the closure or sterilizes the injection site. The surfaces 1, 2 cover two sides of the device of the inserter 3 / base part 4, the upright side 1 covers one side of the inserter 3 and the support side 2 covers the side of the assembly of the base part 4. According to this embodiment , the non-adhesive side of the base part 4 which points upwards in figure 1, is not covered by a rigid surface but will be covered by a soft material which has to be removed before it is possible to remove the inserter including the part base of the package. The non-adhesive side of the mounting pad is the opposite side of the adhesive surface, i.e., if the adhesive surface faces down, the non-adhesive side confronts upwards.

That the package has two sides 1, 2 formed of a rigid material makes it easier for the user to hold the package with one hand and at the same time remove the medical device with the other hand and makes it possible for the user to place the package on a surface Non-sterile and for example, push the package while a cover formed of a soft material comes off. At the same time, it is easy to remove a medical device that has an irregular shape from the packaging.

The second surface can provide a contact surface for the adhesive side of the mounting pad of the base part 4, that is, the mounting pad adheres to the second surface 2 while the base part 4 and the connected mounting pad is placed in the package and the second surface 2 provides a protective layer for the adhesive surface. Alternatively, the mounting pad may be provided with a separate release layer that provides a protective layer for the adhesive surface and whose release layer is removed together with the base portion 4 when the inserter 3 including the base portion 4 is removed from the base. packing.

The package of the assembly shown in Figure 1 is provided with connecting side portions 7, 8 formed of rigid material. The rigid material used to connect the first and second surfaces 1, 2 rigidly joined is according to this embodiment the same material as the first and second surfaces 1, 2 which are formed of four sides currently 1, 2, 7, 8 can be molded as a piece of the same material. The connecting side parts 7, 8 connect the two surfaces 1, 2 rigidly joined together and consequently form a package having a non-flexible structure. This modality makes it easier for the individual package to support external forces that impact the package. It is also simpler to place a soft material that provides sterile conditions within the package along the edge when the flat edge 5 lies on a flat surface.

In the embodiment of figure 1, the first connecting side part 7 is formed with a projected hollow part which is able to surround the activation handle of the inserter 3 and consequently fit closely around the inserter 3 and the base part 4 The second connecting side part 8 is formed with a flat surface having the shape of a flat right angle triangle connected respectively to the first surface 1 and the second surface 2 along each of the sides at right angles. On the inner surface, the second side connection part 8 is provided with a small projected portion 8a which helps to hold the inserter in position while the inserter 3 is in the package when the projected part 8a prevents the inserter 3 and the connected base part 4 move towards the front edge of the package.

Figure 2 shows a second embodiment of an assembly according to the invention, which assembly also comprises a package and an inserter 3 combined with a base part 4 provided with a mounting pad. As in Figure 1, only the rigid packing material is shown in Figure 2.

As for the first embodiment, the rigid material is constructed of two surfaces arranged in an angular manner and rigidly joined together, the first and second surfaces 1, 2 and the packaging are also provided with two connecting side parts 7, 8 and the edge of the four sides of rigid material, has a flat circumferential portion 5 for the releasable connection of a protective seal 10 soft material. As in the first embodiment, a part 6 of the circumferential portion 5 can be separated from the rigid material and can function as a handle, the handle of which can be non-releasably connected to the protective seal of soft material. In Figure 2, the handle 6 is also in the position that holds it before use, while the protective seal of soft material has been removed. The package, internally, that is to say, on the inner surface, is provided with two distance pieces 9 respectively placed on the first and second side connecting parts 7, 8, two small projected parts 8a are placed opposite each other. distance piece 9 and the opposite positioned parts hold the inserter in a well-defined position and make it possible for the user to hold the inserter 3 with a clamp-type jaw of for example the index finger and the thumb.

The second surface 2 also functions as a support for the medical device according to the second embodiment, that is, the medical device can remain on this support while the user, for example, arranges the closure or sterilizes the injection site.

The package of the assembly shown in Figure 2 is also provided with side portions 7, 8 formed of rigid material. The rigid material used to connect the first and second surfaces 1, 2 rigidly joined according to this embodiment, is formed of the same material as the first and second surfaces 1, 2 which are formed of, actually four sides 1, 2, 7, 8- that are molded as a piece of the same material. The lateral connecting parts 7, 8 connect the two surfaces 1, 2 rigidly joined together and consequently form a package having a non-flexible structure.

In the embodiment of Figure 2, the two lateral connecting parts 7, 8 are both formed as a flat surface having the shape of a flat right angle triangle connected in a respective manner to the first surface 1 and the second surface 2 a along each of the right-angle sides.

Figures 3 and 4 show the rigid packaging material of respectively the first and second embodiments without the medical device placed in each part of the package. This view makes it possible to see the pieces of distance 9 in each mode.

Figures 3 and 4 show each embodiment in a side view illustrating how the construction comprising the two articulated surfaces 1, 2 connected by the lateral connecting parts 7, 8 provide the product with a triangular profile when viewed from the side.

Figure 5 illustrates how the first and second modes can be packaged in a pack of ten. A multi-package that contains an equal number of units, that is, 2, 4, 6, 8, 10, etc., will be very resistant to impacts from the surroundings and will occupy very little space during storage, that is, the packaging is Easy to pack in large quantities and provides minimal material use.

Figures 6A and 6B respectively show a top view and a bottom view of the first embodiment of the assembly according to the invention. In these views, the rigid and soft parts of the package are joined and from Figure 6B it can be seen how the soft protective material 10 is connected to the circumferential portion 5 of the rigid material 1, 2, 7, 8.

Figures 7A and 7B show respectively a top view1 and a bottom view of the second embodiment of the assembly according to the invention. In these views, the rigid and soft parts of the package are joined and from Figure 7B, it can be seen how the soft protective material 10 is connected to the circumferential portion 5 of the rigid material 1, 2, 7, 8.

Figure 8A illustrates the different layers that will normally be present along the circumferential portion 5 and that will cover the opening of the rigid material: I. The first layer is closest to the rigid material * and consists of a molten layer, for example, formed of polyethylene. This molten layer is placed along the circumferential portion 5 of the rigid material.

II. The second layer is placed on top of the molten layer and consists of a sticky layer, for example, formed of polyamide. The molten layer is used during the manufacture of the package to connect to a top layer.

III. The third layer provides at least partially an outer surface of the package, i.e., the layer is an upper layer and consists of paper or plastic (eg, PET) of a relatively strong material. The upper layer covers the circumferential portion 5 and the opening of the rigid material. When the user releases the upper layer; the connection to the molten layer is broken and the exposed sections of the sticky layer provide portions to which the top layer can adhere so that the gasket can be resealed.

IV. The fourth layer, for example, is formed of paper and can provide a surface which is suitable to show, for example, the name of the manufacturer.

Figure 8B shows a mechanism for resealing the package opened after use. When in motion, the user may not always have access to a deposit. This means that the user has to take the used unhygienic parts in a bag or pocket and this creates the need to be able to reuse the packaging and preferably reseal the packaging to keep the insertion needle especially away from contact with other people.

A resealing mechanism can be of a chemical or mechanical type. If the reseal is chemical, the reseal mechanism normally comprises a sticky layer II placed at least in portions of the rigid material and / or soft protective material 10 in position where the soft protective material 10 can be joined to the rigid material after the Medical device has been used and after that replaced inside the packaging.

If the resealing is mechanical, it may be of the type shown in Figure 8B. The cap or upper layer comprising the soft protective material 10 covers the opening provided by the circumferential portion. The upper layer has a series of holes 13 along one edge (three holes are shown in Figure 8B).

A portion of the circumferential portion 5 of the rigid material has a rim 14 in which a folded edge 15 of the top layer 10 is placed when the mechanism is closed. When the mechanism is closed, projected portions of the rigid material project through the holes 13 formed in the upper layer.

Figure 8C shows a three-dimensional view of a package provided by an upper layer III and a fourth layer IV. The top layer corresponds to the soft protective material 10 that can be formed of paper or plastic or other material with similar characteristics.

Figures 9A and 9B show a medical device that can be used appropriately with an assembly according to the invention. The medical device comprises an inserter 3 and a base part 4. Before the medical device is removed from the package and put into use, the inserter 3 must be releasably connected to the base part 4, this eliminates the act where the user you have to attach the inserter to the base part or a part of the cannula. When the inserter; 3 is connected to the base part 4, which is the situation before use, the combined unit is relatively large and relatively brittle so that it will also be possible to separate the inserter 3 from the base part 4 before the base part 4 has been correctly placed on the skin of the patient and the cannula part has been inserted. The packaging according to the invention prevents this separation from occurring during storage and transportation.

The device in Figures 9A and 9B is shown in a situation just after the insertion of the cannula part, where the inserter has been released from the base part 4. The base part 4 comprises a plate in the form of a mounting surface flat in which a reservoir and supply means in the form of a pump and for example, a control means can be placed and therefore transported by the user.

An inserter 3 and a base part 4 are known from the Danish patent application PA200800185 (filing date: 'February 8, 2008) and the embodiments of the inserter and the base part described in figures 12-19 of this application are incorporated in the present for reference.

Claims

1. An assembly that includes: a medical device comprising a mounting pad having an adhesive surface and an inserter whose inserter comprises an insertion needle and - a package that provides a sterile protection for the medical device whose packaging partially comprises a rigid material and partially a soft material, characterized in that the rigid material consists of four sides of rigid material comprising: - two sides having angularly placed and rigidly joined surfaces, first and second surfaces, the surfaces of which cover two sides of the medical device respectively, the adhesive surface of the mounting pad and one side of the inserter whose sides of the device doctor confront two different directions, and, - The: non-adhesive surface of the mounting pad is not covered by a rigid surface and - two sides connecting the first and second rigidly joined surfaces and covering opposite ends of the inserter whereby they form a non-flexible structure.

2. The assembly according to claim 1, characterized in that the edge of the four sides of the rigid material has a flat circumferential portion for releasable connection of the protective seal of soft material.

3. The assembly according to claim 1, characterized in that the second surface provides a contact surface for the adhesive surface of the mounting pad.

4. The assembly according to claim 1 or 2, characterized in that the first side and the second side are placed at a right angle with respect to each other.

5. The assembly according to any of the preceding claims, characterized in that the edge of rigid material has a flat circumferential portion, which surrounds an opening defined by the edge of rigid material to which the circumferential portion of a protective seal can be releasably connected. soft material

6. The assembly according to any of the preceding claims, characterized in that the rigid material is molded in one piece.

7. The assembly according to any of the preceding claims, characterized in that the package comprises means for resealing.

8. The assembly according to claim 7, characterized in that the means for resealing comprises adhesive and / or mechanical means.

9. The assembly according to claim 8, characterized in that the means for resealing is provided by an adhesive or sticky material placed between the soft material and the circumferential portion.

10. The assembly according to claim 8, characterized in that the means for resealing is provided by one or more openings in the soft material whose openings correspond to the projected portions of rigid material.

11. The assembly in accordance with any claim; precedent, characterized in that the inserter of the medical device is releasably connected to a base part, whose base part will be placed on the skin of a patient, whose base part is of such a size that a supply part comprising a reservoir can be directly connected to the base part.

12. A package that provides a sterile protection for a medical device stored in the package, whose packaging partially comprises a rigid material and partially a soft material characterized in that the rigid material consists of four sides of rigid material; - two surfaces arranged in an angular manner and rigidly joined, first and second surfaces, the surfaces of which cover two sides of the medical device respectively, the adhesive surface of the mounting pad and one side of the inserter whose sides face two different directions and the Non-adhesive surface of the mounting pad is not covered by a rigid surface and two lateral parts connecting the two rigidly joined surfaces which consequently form a non-flexible structure.